Maquet Medical Systems USA is recalling 1,595 units of the CARDIOHELP-i Heart Lung Support System because the Instructions for Use incorrectly described factory and default settings for critical safety features. This includes incorrect warning limits for blood pressure (PVen and PAux) and incorrect default settings for the venous bubble sensor and automatic lock in certain applications. These errors could lead to a clinician misinterpreting system alerts or safety protocols during cardiac or pulmonary bypass procedures.
Incorrectly programmed warning limits or bubble sensor settings could cause a failure to detect or respond to dangerous air bubbles or pressure changes in the blood circuit. This may result in serious patient harm, including blood clots, air embolisms, or inadequate circulatory support during life-sustaining procedures.
Corrective instructions and manual updates
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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